COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (β-TGIC)	
CAS number:	59653-74-6	
EC number:	423-400-0	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: CMR

Disclaimer: comments provided during public consultation are made available in this document as submitted by the webform. It was in the “interested parties” own responsibility to ensure that no confidential information was included in the comments. In addition, ECHA is not responsible for the content of the responses prepared by Member States.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
7	2012/04/12	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as mutagen category 1B.
	Thank you.	
5	2012/04/11	Member State
Sweden	The Swedish CA agrees that β-TGIC, being classified as Muta. 1B, meets the criteria according to Article 57(b) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you.	
4	2012/04/11	Company
Japan	We previously notified Beta TGIC and have since claimed a REACH Registration for this substance.  We are the only company to possess a Registration for this substance.  The “PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR CATEGORY 1A OR 1B, PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN” contains fundamental misunderstandings about the substance and is factually incorrect in relation to its uses.  We wish to address these points.
Therefore as Beta TGIC is marketed as a distinct substance, is exclusively used in solder mask ink use and is handled under strictly controlled conditions (as detailed in our comments on Section II) we consider that this should not be added to the Candidate List for Authorisation.	Thank you for your comment and supplied additional information. The supporting document for β-TGIC will be updated. It should be noted, that no registration dossier is available on the ECHA website yet.	
3	2012/04/11	Member State
Germany	The German CA supports the identification of beta-TGIC as SVHC.

	Thank you.	
2	2012/04/11	Member State
Norway	The Norwegian CA supports that beta-TGIC (1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione) should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you.	
1	2012/04/06	Member State
Belgium	Belgium supports the identification of β-TGIC as SVHC according to article 57 (b)	Thank you.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
6	2012/04/11	Member State
Ireland	β-TGIC is classified as Muta. 1B according to Regulation EC No. 1272/2008, and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (b) of REACH.	Thank you.	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
4	2012/04/11	Company
Japan	Substance identity (page 10):
Beta-TGIC is a monoconstituent isomeric substance with low level of alpha TGIC present as an impurity.  Beta-TGIC is manufactured, placed on the market and used as a separated substance.  It is not synonymous with the mixed isomeric form of TGIC and is a distinct and separately marketed substance.  Information presented in page 10 is therefore incorrect.

Production and use volumes (page 10):
Beta-TGIC has been Registered under REACH for supply at up to 10 tonnes per year.  Actual supply is within this limit.  Beta-TGIC is a niche substance and not a high volume substance.  Information presented on tonnages on page 10 is therefore incorrect and significantly overestimates volumes.

Uses of the substance (page 11):
As we are the only company who possess a Registration of Beta TGIC, and we have conducted extensive discussions with our downstream users on a global basis, we can be confident about applications in which this substance is used.  Beta TGIC is used exclusively in solder mask ink applications.  There is absolutely no use in other applications, specifically it is not used in powder coatings, electrical insulation materials, resin-moulding systems, laminated sheetings, silk-screen printing coatings, tools, inks, adhesives, lining materials, and stabilizers for plastics (contrary to statements made on page 11).
Furthermore the only life cycle stage which occurs in the EU with Beta-TGIC is “use of solder mask ink”.  It has been confirmed that “Manufacture of solder mask ink” does not occur in the EU with Beta TGIC.

Information on exposure (pages 12-17):
The only life cycle stage which occurs in the EU with Beta-TGIC is “use of solder mask ink”.  All other life cycle stages and applications (including powder coating) as mentioned on page 12-17 are not relevant.
Use of solder mask ink is undertaken under clean room conditions under closed systems with LEV in operation throughout (although not an intermediate, substance is handled under strictly controlled conditions).  Transfer of liquid solder mask ink to the coating machine also occurs with LEV in operation to control exposure to workers.  As a supplemental precaution to ensure exposure to workers is avoided, workers also wear clean work wear, gloves, goggles and respirator during the charging process.  All subsequent treatment stages occur in a closed system with LEV in operation.  After the curing stage Beta-TGIC is no longer present as it is fully reacted.

Information on alternatives (page 18-19) and Risk related information (page 20):
Mention of powder coating related information is not relevant as Beta TGIC is not used in these applications.	Thank you for your comment and supplied additional information. The supporting document for β-TGIC will be updated. It should be noted, that no registration dossier is available on the ECHA website yet, therefore update of the supporting document is done based only on your comments.